This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.
The DASTOP2 study aims to retreat patients who relapse in the Euro-SKI study (or who stopped TKI treatment outside trials but according to EURO-SKI procedures), with TKI for at least another 3 years, out of last two years with dasatinib. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted. Patients exhibiting hematological relapse after first stop attempt will not be offered a second stop within this study. The same applies to patients in whom TKI was restarted prematurely (without loss of MMR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
134
CML patients who have failed a first stopping attempt and have used any TKI for one year will switch to dasatinib 100 mg qd for an additional 2 years before second stop attempt.
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGsuccessful MMR maintenance
The proportion of patients maintaining MMR at 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1 \> 0.1% on IS at one time point).
Time frame: one year
correlates with succesful stop
Assessment of clinical and biological factors correlating with persistence of MMR or better after second TKI stop.
Time frame: 1 year
reachievement of MR4
Number of patients who re-achieved stable MR4, and were offered study participation.
Time frame: 1 year
Time to reachievement of MR4
Time to reachievement of MR4 after second loss of MMR.
Time frame: 1 year
Adverse events after TKI withdrawal
Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.
Time frame: 1 year
Overall survival
Overall survival
Time frame: 1 year
Progression-free survival
Progression-free survival
Time frame: 1 year
TKI restart without prior molecular relapse
Occurrence of a restart of TKI without prior molecular relapse.
Time frame: 1 year
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Odense University Hospital
Odense, Denmark
RECRUITINGHelsinki University Hospital
Helsinki, Finland
RECRUITINGCentre Hospitalo-Universitaire
Créteil, France
NOT_YET_RECRUITINGUniversity Hospital
Bonn, Germany
RECRUITINGVU University medical center
Amsterdam, Netherlands
NOT_YET_RECRUITINGAlbert Schweitzer Hospital
Dordrecht, Netherlands
NOT_YET_RECRUITINGRadboud University medical center
Nijmegen, Netherlands
NOT_YET_RECRUITINGErasmus University medical center
Rotterdam, Netherlands
NOT_YET_RECRUITINGHaukeland, Bergen University Hospital
Bergen, Norway
RECRUITING...and 11 more locations